Interest of Bone Substitute Material in Immediate Complete Denture (PANORAMIX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02120053
First received: April 15, 2014
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.

The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.

After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.

However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.

Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.


Condition Intervention Phase
Alveolar Bone Loss
Denture Complete Immediate
Bone Substitute
Replacement Material
Bone
Device: Conventional protocol
Device: Bone substitute material group
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets [ Time Frame: one year (365 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year [ Time Frame: Day 10, Day 90, Day 365 ] [ Designated as safety issue: No ]
    To compare bone ridge width one year after maxillary immediate complete denture placement with and without bone substitute material in incisive-canine sockets: height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year


Estimated Enrollment: 34
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone substitute material group
Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
Device: Bone substitute material group
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
Active Comparator: Conventional protocol
Immediate denture placement following the conventional protocol
Device: Conventional protocol
Teeth extractions and conventional immediate complete denture placement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for maxillary immediate complete denture, presenting a Kennedy
  • Class I partial dentition (bilateral posterior tooth loss)
  • Over 18 years of age
  • Healthy adhering gingiva
  • Willing to participate in the study, able to sign the consent form

Exclusion Criteria:

- Medical conditions contraindicating oral surgery: progressive cancer history of radiotherapy in the head and neck region major neurological disease anti-coagulant treatment with prothrombin time<30% valvulopathy, hematologic disease, agranulocytosis, serious heart failure, recent myocardial infarction < 5 years immune deficiency, AIDES osteomalacia hepatic or renal insufficiency unregulated diabetes long-term steroids treatment bisphosphonates

  • Allergy to collagen
  • Pregnant or nursing women
  • Persons specially protected
  • Non-affiliated with the social security system persons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120053

Contacts
Contact: Christophe Rignon-Bret, DDS, PhD 1 49 81 33 33 ext +33 christophe.rignon-bret@parisdescartes.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Christophe Rignon-Bret, DDS, PhD    1 49 81 33 33 ext +33    christophe.rignon-bret@parisdescartes.fr   
Contact: Fatiha Djennaoui, CRA    1 49 81 33 84 ext +33    fatiha.djennaoui@hmn.aphp.fr   
Principal Investigator: Christophe Rignon-Bret, DDS, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Geistlich Pharma AG
Investigators
Principal Investigator: Christophe Rignon-Bret, DDS, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02120053     History of Changes
Other Study ID Numbers: P111116, AOR12032
Study First Received: April 15, 2014
Last Updated: April 18, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Immediate complete denture
Alveolar ridge resorption
Alveolar bone loss
Bone substitute material
Edentulism

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014